FDA Accepts Astellas Pharma's Revised SNDA for ISERVAY in the Treatment of Geographic Atrophy

(RTTNews) – Astellas Pharma Inc. (ALPMY, ALPMY) announced that the US Food and Drug Administration has accepted a revised supplemental new drug application, or sNDA, for ISERVAY (avacincaptad pegol intravitreal solution) for the treatment of secondary geographic atrophy (GA). age-related macular degeneration (AMD) on January 6, 2025, in response to the Agency’s November 2024 Letter complete response rate (CRL).

The company noted that the application was resubmitted following a December 20, 2024 meeting between the FDA and Astellas and was designated as a Class 1 resubmission with a 60-day review period.

A target date of action has been set for 26 February 2025.

ISERVAY was approved by the US Food and Drug Administration on August 4, 2023, for the treatment of geographic atrophy secondary to macular degeneration.

The sNDA seeks to add positive 2-year data to the IZERVAY US prescribing information based on the results of the Phase 3 GATHER2 clinical trial.

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